MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA HIP GENERAL OFFSET-30° BROACH HANDLE - LEFT; SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.10.10.131
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 23 april 2019: lot 1211439b: (b)(4) items manufactured and released on 10-apr-2018.No anomalies found related to the problem.To date, no similar event has been reported on this lot.Additional instrument involved in the complaint: hip general 01.10.10.130 offset-30° broach handle - right lot.1851540: (b)(4) items manufactured and released on 26 july 2018.No anomalies found related to the issue.To date, another similar event has been reported on this lot.Visual inspection performed by r&d (b)(4).The spring ball plunger is came apart.It is possible this occurrence was influenced by variation in production/assembly however this cannot be confirmed.
Event or Problem Description
During the impaction the instrument ball spring fell out the passing hole and the spring was broken.The ball did not fall in the patient.The surgery was completed successfully using a straight broach handle.The same day the surgeon had a second identic case with a second broach handle.

• Brand Name: HIP GENERAL OFFSET-30° BROACH HANDLE - LEFT
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8555124
• Report Number: 3005180920-2019-00315
• Device Sequence Number: 16702516
• Product Code: LXH
• UDI-Device Identifier: 07630040742122
• UDI-Public: 07630040742122
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 01.10.10.131
• Device Lot Number: 1211439B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other